WO2022031560A1 - Méthodes fiables et évolutives de détection et plate-forme pour dispositifs médicaux de consommateur - Google Patents

Méthodes fiables et évolutives de détection et plate-forme pour dispositifs médicaux de consommateur Download PDF

Info

Publication number
WO2022031560A1
WO2022031560A1 PCT/US2021/044091 US2021044091W WO2022031560A1 WO 2022031560 A1 WO2022031560 A1 WO 2022031560A1 US 2021044091 W US2021044091 W US 2021044091W WO 2022031560 A1 WO2022031560 A1 WO 2022031560A1
Authority
WO
WIPO (PCT)
Prior art keywords
target
sample
testing
sample solution
strip
Prior art date
Application number
PCT/US2021/044091
Other languages
English (en)
Inventor
Sheena Ruby Menezes
Jerzy Majka
Quynh Nga Thi LE
Vicky Chen
Linus Aranha
Original Assignee
Simple Healthkit, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Simple Healthkit, Inc. filed Critical Simple Healthkit, Inc.
Priority to EP21852382.7A priority Critical patent/EP4189393A1/fr
Publication of WO2022031560A1 publication Critical patent/WO2022031560A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/571—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses for venereal disease, e.g. syphilis, gonorrhoea
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/046—Function or devices integrated in the closure
    • B01L2300/047—Additional chamber, reservoir
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips

Definitions

  • the invention(s) described relate generally to multiplexed systems, kits, devices, and methods for reliably and efficiently assessing sexual health of a subject.
  • Embodiments of the invention(s) described relate to consumer multiplexed, rapid test devices and kits that can be used to detect a target, such as the presence of two or more infections caused by a sexually transmitted pathogen, optionally in conjunction with the detection of pregnancy, fertility, and/or other sexual health conditions.
  • Methods for producing the system(s) described are also described.
  • STIs sexually transmitted infections
  • system(s) and method(s) described herein include system components, assay materials, and additional elements for enabling rapid and reliable characterizations of two or more health conditions (e.g., sexual health conditions) of a subject in a multiplexed manner with reduced error and contamination.
  • health conditions e.g., sexual health conditions
  • embodiments of the invention(s) described can outperform existing tests for detection of sexual health statuses, in relation to comprehensively and efficiently testing for a panel of different pathogens in a streamlined, multiplexed format.
  • embodiments of the invention can efficiently test for statuses of infections associated with the following agents in multiplexed formats: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Gardnerella vaginitis, Candida Albicans, Mycoplasma genitalium, estrogen, progesterone, testosterone, anti-mullerian hormone, follicle-stimulating hormone, luteinizing hormone, estradiol, thyroid-stimulating hormone, free thyroxine, prolactin, human immunodeficiency virus, human papillomavirus infection, Hepatitis B, and herpes simplex virus.
  • Embodiments of the invention(s) also produce increased sensitivity and/or specificity in test results by incorporating multiple test strips associated with different target material regions of the agents/biomarkers assessed, each independently assessed in their own respective testing container within a single device.
  • Embodiments of the invention(s) also assess other sexual health conditions (e.g., statuses of pregnancy, statuses of fertility).
  • Embodiments of the invention(s) described also include custom extraction and processing buffer compositions for each health condition tested for that facilitate easy sample processing, especially in a consumer kit format.
  • Embodiments of the invention(s) described also include effective reaction and testing substance compositions (e.g., aptamers, antibodies, etc.) that produce appropriate binding characteristics with sample target material and do not cross react, thereby enabling multiplexed format testing.
  • the consumer kit includes a device designed in a simple, streamlined form factor for holding more than one test strip in a stable manner, separated from the adjacent strip(s) to avoid cross-contamination, while also positioning them for insertion at the appropriate depth into a specific corresponding well for that strip containing the relevant reagents and/or buffer along with the sample from the user for testing.
  • the design of the device allows the user to easily place the ends of all strips into the corresponding wells simultaneously by simply placing the device on or over the wells, thus minimizing the chance that the user makes a mistake, such as inserting too much or too little of the strip into the well, inserting a strip into the incorrect well or cross-contaminating the strips, tipping over the wells and spilling the contents, etc.
  • a system for detecting status of one or more health conditions includes: an extraction container for receiving a biological sample collected by a sample collection tool, the extraction container capable of containing a first buffer for extracting a target material associated with one or more health conditions from the sample to form a sample mixture comprising the target material and the first buffer; a testing container comprising: a holder comprising at least a first well configured to receive the sample mixture, wherein the first well comprises one or more additional buffers, that, when mixed with the sample mixture, form a first target sample solution in the first well, the one or more additional buffers associated with the one or more health conditions; and a base of the holder; a signal output device comprising a housing containing at least a first strip secured within the housing, wherein an end portion of the first strip is positioned within the signal output device for being placed into fluid communication with the first target sample solution of the first well, the signal output device configured to provide an indication of a status of
  • a system for detecting status of eone or more health conditions includes: an extraction container for receiving a biological sample collected by a sample collection tool, the extraction container capable of containing a first buffer for extracting a target material associated with one or more health conditions from the sample to form a sample mixture comprising the target material and the first buffer; a testing container comprising: a holder comprising at least a first and second well configured to receive the sample mixture, wherein the first and second well each comprise one or more additional buffers, that, when mixed with the sample mixture, form a first target sample solution in the first well, and a second target sample solution in the second well, the one or more additional buffers associated with the one or more health conditions; and a base of the holder; a signal output device comprising a housing containing at least a first and second strip secured within the housing, wherein an end portion of the first strip is positioned within
  • each of the one or more additional buffers within the first and second wells is associated with a health condition.
  • the housing of the signal output device completely or partially surrounds the first and second strips.
  • the housing is sized to fit over an upper portion of the target container, above the base, to allow the first and second strips to be lowered into the first and second well.
  • the housing of the signal output device is configured to sit on top of the testing container.
  • the housing of the signal output device comprises at least one wedge or peg configured to prevent movement or displacement of each of the at least first and second strips within the housing. [0017] In some embodiments, further comprising one or more pressure points at one or more locations within the housing configured to prevent movement or displacement of the first and second strips.
  • the one or more pressure points are configured to provide vertical fluid flow or horizontal fluid flow of the first and second target sample solution.
  • the housing further comprises at least a first and second window for viewing the first and second strips and reading the indication of the status of the one or more health conditions.
  • each strip comprises: an absorbent pad, a conjugate release pad, a wicking pad, a test line, and a control line.
  • each strip further comprises a backing card and a sample pad.
  • each strip comprises one or more of: an absorbent pad, a conjugate release pad, a wicking pad, a test line, a control line, a backing card, and a sample pad.
  • each strip comprises one or more of: an absorbent pad, a conjugate release pad, a wicking pad, a membrane, a test line, a control line, a backing card, and a sample pad.
  • each strip of the one or more strips comprises: a loading zone capable of receiving the target sample solution; a reaction zone coupled to the loading zone and comprising a first reaction substance conjugated to a first label, wherein the first reaction substance is capable of preferentially coupling to a first target of the target material within the target sample solution, a testing zone coupled to the reaction zone and comprising a first testing substance retained at a first region of the testing zone, wherein the first testing substance is capable of preferentially coupling to the first target of the target material within the target sample solution; and a control zone comprising a control substance retained at the control zone, wherein the control substance is not capable of preferentially coupling to the target material within the target sample solution.
  • a health condition of the one or more health conditions is an infectious disease caused by at least one of a bacterial agent, viral agent, or a parasitic agent.
  • a health condition of the one or more health conditions is a health condition associated with at least one of a Streptococcus pyogenes infection, Chlamydia trachomatis infection, a Neisseria gonorrhoeae infection, a Trichomonas vaginalis infection, a Treponema pallidum infection, a Gardnerella vaginitis infection, human immunodeficiency virus, human papillomavirus infection, Hepatitis B, herpes simplex virus, a fertility status, a pregnancy status, or a women’s health status.
  • the system or kit of the present disclosure relates to detecting a women’s health status.
  • the health condition is associated with at least one of a Streptococcus pyogenes infection, influenza, common cold, and the like.
  • the women’s health condition is associated with at least one of: estrogen, progesterone, testosterone, anti-mullerian hormone, follicle-stimulating hormone, luteinizing hormone, estradiol, thyroid-stimulating hormone, free thyroxine, and prolactin.
  • the health condition is a women’s health condition.
  • the health condition is associated with an infectious disease.
  • the dropper cap comprising a dropper cap, the dropper cap fitted to the extraction container.
  • the stirrer comprises two or more arms.
  • the stirrer comprises a first arm configured to stir the first target sample solution, and a second arm configured to stir the second target sample solution.
  • the sample collection tool is configured to mix the first buffer and the sample to form the sample mixture.
  • the signal output device further comprises at least a third strip, wherein an end portion of the third strip is in fluid communication with the third target sample solution of the third well, the signal output device configured to provide an indication of a status of the one or more health conditions for the third target sample solution in the third well. [0032] In some embodiments, further comprising the sample collection tool for collecting the sample.
  • the sample is one of a vaginal fluid, a vaginal tissue, a vaginal washing, a vaginal swab, a vaginal discharge, a cervical swab, a cervical tissue urethral swab, a urethral discharge, a rectal swab, a rectal material, a rectal washing, urine, blood, serum, plasma, saliva, tears, a skin swab, semen, seminal fluid, sputum, bronchial fluid, bronchial washing, peritoneal fluid, peritoneal washing, pleural fluid, pleural washing, cerebrospinal fluid, eye fluid, eye tissue, lung fluid, lung tissue, liver fluid, liver tissue, heart fluid, heart tissue, brain fluid, brain tissue, kidney fluid, kidney tissue, spleen fluid, spleen tissue, muscle fluid, muscle tissue, nasal fluid, nasal swab, throat fluid, or throat swab
  • the signal output device is capable of being signal processed using at least one of an optical sensor, optical reader, or a smartphone.
  • the at least first and second wells are separately housed within the testing container, and wherein the at least first and second wells are not fluidically connected.
  • the housing further comprises at least a first chamber configured to hold the first strip, and a second chamber configured to hold the second strip, and wherein the first and second chambers are not fluidically connected.
  • a sample kit comprising: an extraction container for receiving a sample collection tool for mixing of the sample with a buffer within the extraction container to form a sample mixture and for performing a first step in an extraction process to extract from the sample, where present, the following: a first target material from one or more agents associated with a first health condition, and a second target material from one or more agents associated with a second health condition; a testing container for receiving, from the extraction container, the sample mixture comprising the buffer mixed with the sample, the testing container having at least the following: a first well containing one or more first reagents specific to the first health condition, the first well for receiving a portion of the sample mixture to combine with the one or more first reagents as a first target sample solution, and a second well containing one or more second reagents specific to the second health condition, the second well for receiving a portion of the sample mixture to combine with the one or more second reagents as a second target sample solution; and a signal output device having
  • the kit further comprises the sample collection tool for collecting the biological sample from a subject to test the subject for at least the first health condition and a second health condition.
  • the testing container comprises at least a third well containing one or more third reagents specific to a third health condition, the third well for receiving a portion of the sample mixture to combine with the one or more second reagents as a third target sample solution.
  • the signal output device further comprises a third test strip, wherein, upon coupling of the housing to the testing container, the third test strip fluidically contacts the third target sample solution, the third test strip including one or more zones with substances for interaction with the third target material to indicate whether the third health condition is present.
  • the one or more reagents in each of the first and second wells comprise one or more buffers for being held within each of the first and second wells.
  • the target material comprises a biomarker of a pathogen that causes the sexually transmitted infection
  • the buffer within the extraction container, the testing container, or both the extraction container and testing container comprises one or more of: sodium hydroxide, potassium hydroxide, mM sodium chloride, mM potassium chloride, sulfuric acid or nitric acid or hydrochloric acid, PBS (phosphate buffered saline), TBS (Tris buffered saline), tricine, HBS (HEPES buffered saline), 3-[(3- Cholamidopropyl) dimethylammonio]-l -propanesulfonate, BugBusterTM, octylthioglucoside, Triton X-100, octyl glucoside, chicken albumin, casein, bovine albumin, a crowding agent such asl000-100000 dextran, 3500-20000 polyethylene glycol, Polyamines, amino acids, a non-choline, Triton X
  • the target material comprises a biomarker of a pathogen that causes the sexually transmitted infection
  • the buffer within the extraction container, the testing container, or both the extraction container and testing container comprises one or more of: 5-500mM sodium hydroxide, 5-500mM potassium hydroxide, 1- 2000 mM sodium chloride, 1-2000 mM potassium chloride, 5-500mM sulfuric acid or 5- 500mM nitric acid or 5-500mM hydrochloric acid, 1-50 % PBS (phosphate buffered saline), 1-50 % TBS (Tris buffered saline), 1-50% tricine, 1-50% HBS (HEPES buffered saline), 00.
  • each strip of the one or more strips comprises:
  • a loading zone capable of receiving the target sample solution; a reaction zone coupled to the loading zone and comprising a first reaction substance conjugated to a first label, wherein the first reaction substance is capable of preferentially coupling to a first target of the target material within the target sample solution, a testing zone coupled to the reaction zone and comprising a first testing substance retained at a first region of the testing zone, wherein the first testing substance is capable of preferentially coupling to the first target of the target material within the target sample solution; and a control zone comprising a control substance retained at the control zone, wherein the control substance is not capable of preferentially coupling to the target material within the target sample solution.
  • aspects of the present disclosure provides a method comprising: receiving, from a first device, a request for a sample kit of Claim 25, the sample kit to test a subject for at least a first health condition; receiving, from a second device, an image of a result of the sample kit; reading the result of the sample health kit from the image of the result; providing for display the result on a user interface of the first device; and receiving, from the first device, a request for a prescription for the subject based, in part, on the result.
  • reading the result comprises reading a signal outputted by a signal output device of the sample kit using labels.
  • at least one label of the labels is one of a visual label, gold nanoparticles, colored latex beads, magnetic particles, carbon nanoparticles, cellulose nano beads, selenium nanoparticles, silver nanoparticles, quantum dots, up converting phosphors, organic fluorophores, textile dyes, enzymes, liposomes or similar labels.
  • a device for determining the presence or absence of one or more health conditions comprising: a signal output device comprising a housing containing at least a first strip, wherein an end portion of the first strip is capable of being placed into fluid communication with a first target sample solution of a first well of an testing container, the signal output device configured to provide an indication of a status of the one or more health conditions for the first target sample solution.
  • a device for determining the presence or absence of one or more health conditions comprising: a signal output device comprising a housing containing at least a first strip, wherein an end portion of the first strip is capable of being placed into fluid communication with a first target sample solution of a first well of an testing container, the signal output device configured to provide an indication of a status of the one or more health conditions for the first target sample solution.
  • a device for determining the presence or absence of one or more health conditions comprising: a signal output device comprising a housing containing at least a first and second strip, wherein an end portion of the first strip is capable of being placed into fluid communication with a first target sample solution of a first well of an testing container, and an end portion of the second strip is capable of being placed into fluid communication with a second target sample solution of a second well of the testing container, the signal output device configured to provide an indication of a status of the one or more health conditions for the first target sample solution and the second target sample solution.
  • the housing of the signal output device completely or partially surrounds the first and second strips.
  • the housing is sized to couple over an upper portion of the target container, above the base, to allow the first and second strips to be lowered into the first and second well.
  • the housing of the signal output device is configured to sit on top of the testing container. [0055] In some embodiments, the housing of the signal output device comprises a wedge or peg configured to prevent movement or displacement of each of the at least first and second strips within the housing.
  • the one or more pressure points is configured to provide vertical flow or horizontal fluid flow of the first and second target sample solution.
  • the housing further comprises at least a first and second window for viewing the first and second strips and reading the indication of the status of the one or more health conditions.
  • each strip comprises: an absorbent pad, a conjugate release pad, a wicking pad, a test line, and a control line.
  • each strip further comprises: a sample pad, and a backing card.
  • each strip of the one or more strips comprises: a loading zone capable of receiving the target sample solution; a reaction zone coupled to the loading zone and comprising a first reaction substance conjugated to a first label, wherein the first reaction substance is capable of preferentially coupling to a first target of the target material within the target sample solution, a testing zone coupled to the reaction zone and comprising a first testing substance retained at a first region of the testing zone, wherein the first testing substance is capable of preferentially coupling to the first target of the target material within the target sample solution; and a control zone comprising a control substance retained at the control zone, wherein the control substance is not capable of preferentially coupling to the target material within the target sample solution.
  • FIG. 1 illustrates a system for assessing health of a subject, according to one embodiment.
  • FIG. 2 illustrates a perspective view of the testing container shown in FIG. 1, according to one embodiment.
  • FIG. 3 illustrates perspective views of the signal output device shown in FIG. 1, according to one embodiment.
  • FIGs. 4A-4E illustrate different cross-sectional views of the signal output device shown in FIG. 1, according to one embodiment.
  • FIG. 5 illustrates a phase of usage of system components shown in FIG. 1, according to one embodiment.
  • FIG. 6 illustrates an additional phase of usage of system components shown in FIG. 1, according to one embodiment.
  • FIG. 7 illustrates an additional phase of usage of system components shown in FIG. 1, according to one embodiment.
  • FIGs. 8A-8C illustrate an additional phase of usage of system components shown in FIG. 1, according to one embodiment.
  • FIG. 9 illustrates sample data showing system design is scalable for functional detection for different health conditions, according to one embodiment.
  • FIG. 10 provides instructions for using the sample kit according to one embodiment.
  • FIG. 1 illustrates a system for assessing health of a subject, according to one embodiment.
  • the system also referred to as “test kit” herein
  • the system can be configured to indicate statuses of different health conditions in a uni-plexed and/or a multiplexed manner.
  • a set of health conditions e.g., strep throat, flu, sexual health conditions, women hormones etc.
  • the system can be configured to test a sample for presence of different agents associated with the different health conditions.
  • the system and methods can be adapted for the detection status of a health condition or panels including, but not limited to, infectious diseases (including sexually transmitted infections) caused by either bacterial, viral, parasitic agents including, Streptococcus pyogenes, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Gardnerella vaginitis, human immunodeficiency virus, human papillomavirus infection, Hepatitis B, herpes simplex virus, streptococcus pyogenes and/or the relation to pregnancy or fertility.
  • infectious diseases including sexually transmitted infections
  • infectious diseases including sexually transmitted infections
  • infectious diseases including sexually transmitted infections
  • infectious diseases including sexually transmitted infections
  • infectious diseases including sexually transmitted infections
  • infectious diseases including sexually transmitted infections
  • infectious diseases including sexually transmitted infections
  • infectious diseases including sexually transmitted infections
  • infectious diseases including sexually transmitted infections
  • infectious diseases including sexual
  • Additional non-limiting health conditions panels include but are not limited to Candidta Albicans, Mycoplasma genitalium, estrogen, progesterone, testosterone, anti-mullerian hormone, follicle-stimulating hormone, luteinizing hormone, estradiol, thyroid-stimulating hormone, free thyroxine, and prolactin.
  • the system or sample kit for detecting a status of a health condition includes some or all of the following components: a sample collecting tool (e.g., a swab) 105, an extraction container or dropper tube 110, a cover or dropper cap 115, a testing container 120, a stirrer 125, and a signal output device 130.
  • a sample collecting tool e.g., a swab
  • an extraction container or dropper tube 110 e.g., a swab
  • a cover or dropper cap 115 e.g., a testing container 120
  • a stirrer 125 e.g., a swab
  • a signal output device 130 e.g., a signal output device.
  • one sample kit might be designed with all the components needed to test for three STIs, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis.
  • Another sample kit might be designed with all the components needed to test for two STIs and for pregnancy.
  • Another kit might be designed to run multiple fertility tests.
  • a further kit might include all of the components to test for Streptococcus pyogenes, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Gardnerella vaginitis, human immunodeficiency virus, human papillomavirus infection, Hepatitis B, herpes simplex virus, streptococcus pyogenes, pregnancy, and fertility, or any subset of these.
  • the kits can be sold for other types of disease testing and analysis, such as nutrition testing in blood samples, influenza or other disease testing in saliva samples, etc.
  • the sample kit can be designed to include all the components needed for at least 2 tests, at least 3 tests, at least 4 tests, at least 5 tests, at least 6 tests, at least 7 tests, at least 8 tests, at least 9 tests, or at least 10 tests.
  • each test is performed on a separate test strip within the signal output device.
  • the user tests for the same health condition for each test strip.
  • the user tests for different health conditions for each test strip within the sample kit.
  • the sample collecting tool 105 is a swab, such as a vaginal swab, urethral swab, or an endocervical swab.
  • a sample collected by the sample collecting tool 105 include vaginal fluid, vaginal tissue, vaginal washing, vaginal swab, vaginal discharge, cervical swab, cervical tissue urethral swab, urethral discharge, rectal swab, rectal material, rectal washing, urine, blood, serum, plasma, saliva, tears, skin swab, semen, seminal fluid, sputum, bronchial fluid, bronchial washing, peritoneal fluid, peritoneal washing, pleural fluid, pleural washing, cerebrospinal fluid, nasal swabs and/or fluids, throat swabs and/or fluids eye fluid and/or tissue, fluid and/or tissue from lung
  • the sample is a blood sample
  • the sample collecting tool is, e.g., a lancet for piercing a finger and a container or slide for collecting the blood sample).
  • the sample is a urine sample
  • the sample collecting tube is, e.g., a urine collection cup, urine swab, etc.
  • the sample is a vaginal discharge or a penile discharge
  • the sample collecting tool is a swab, cotton pad, sample container, etc.
  • the sample is obtained from contacting an ulcer in genital area
  • the sample collecting tool is a swab, cotton pad, sample container, etc.
  • the sample can be preabsorbed, e.g., to reduce or minimize cross-reactivity and/or background.
  • the biological sample can be preabsorbed with a lysate of bacteria expressing glutathione-S- transferase (GST) and/or a lysate of normal (e.g., non-pathogen infected mammalian cells).
  • GST glutathione-S- transferase
  • absorption of the sample can be with a lysate of pathogen-infected mammalian cells, to remove and/or block chlamydial antigen-specific antibodies from human samples, which can help confirm the specificity of human antibody binding to a test analyte.
  • the sample collecting tool comprises a fluid collecting container.
  • the fluid collecting container comprises a tube.
  • the tube is serum tube or a plasma tube.
  • the sample is or is recommended to be collected at a specific time or in a specific period of time. In some embodiments, the sample is or is recommended to be collected in the morning. In some embodiments, the sample is or is recommended to be collected within 1, 2, 3, 4, 5, 6, or more hours before urinating. In some embodiments, the sample is or is recommended to be collected at noon. In some embodiments, the sample is or is recommended to be collected in the evening. In some embodiments, the sample is or is recommended to be collected before the shower. In some embodiments, the sample is or is recommended to be collected before the individual having sex. In some embodiments, the sample is or is recommended to be collected after the individual having sex.
  • the sample is or is recommended to be collected within 1, 2, 3, 4, 5, 6 or more hours before or after the individual having sex. In some embodiments, the sample is or is recommended to be collected at least 4, 5, 6, 7, 8, 9, 10, 12 days after the individual ovulates.
  • the biological sample is stable at room temperature for at least 1, 2, 4, 8, 12, 16, 20, 24 hours after obtained. In some embodiments, the sample is or is recommended to be tested within 1, 2, 3, 4, 5, 6 hours after it is obtained. In some embodiments, the sample is or is recommended to be tested shortly after it is obtained (for example, within an hour).
  • the extraction of a target material from one or more agents associated with a health condition is accomplished in a single extraction step.
  • the extraction of a target material from one or more agents associated with a health condition is accomplished in at least one or more steps (e.g. at least one step, at least two steps, at least three steps, etc.).
  • the extraction can include an “A-B” buffer system or in a two- or more step reaction or reagent addition, or alternatively a single buffer system or in a one or two or more step reaction or reagent addition.
  • the reagents can be buffers solutions or other types of reagents, including small molecule or chemical reagents, large molecule reagents (e.g., enzymes, antibodies, DNA, RNA, oligonucleotides, primers, probes, labels, tags, etc.).
  • small molecule or chemical reagents e.g., enzymes, antibodies, DNA, RNA, oligonucleotides, primers, probes, labels, tags, etc.
  • the swab or biospecimen is extracted in buffer A, such as a universal buffer, in the extraction container.
  • the extraction container may be, for example, a dropper tube 110.
  • the dropper tube 110 is prefilled with buffer A.
  • buffer A is provided in a separate container, and a user may pour buffer A into the dropper tube 110 before and/or during use of the test kit.
  • buffer A settles to the bottom of the dropper tube 110.
  • the extraction container can be designed in formats other than a dropper tube/dropper cap.
  • the container could have a dropper that sits inside and is pulled out of the container and then used to deliver drops of the material.
  • the container could be designed with a controlled pouring spot to pour out certain amounts of material, or with a plunger and stopper to eject a certain amount of material from the container, or as a simple test tube, beaker, or flask design. The description below is focused on the dropper design for illustration, but it also is applicable to alternative extraction container designs.
  • a user may place the dropper cap 115 onto the dropper tube 110 (FIG. 5).
  • the dropper design allows the sample mixed within the buffer (e.g., sample mixture) to be poured out slowly a single drop at a time or a few drops at a time, to allow controlled release of the sample.
  • the dropper tube 110 with dropper cap 115 are just one embodiment of an extraction container design. In other embodiments, there can be a plastic or glass dropper inside the tube with an end that can be squeezed to release drops. In further embodiments, there is no cap or cover, and the tube/container 110 is used to pour the sample/buffer mixture or solution out of the container.
  • the dropper tube 110 can have other shapes besides a tube, such as a test tube, beaker, or Erlenmeyer flask shape.
  • an alternate cap may be provided to replace the dropper cap 115 if the sample is to be stored or refrigerated for a period of time.
  • the extraction container or dropper tube 110 includes a stirring component, such as a ball or weight that can be shaken inside to mix.
  • the dropper tube 110 can also include a magnetic stir bar to allow for stirring by use of a magnet.
  • the dropper tube 110 and dropper cap 115 can be made of various materials including plastic, glass, rubber, etc., and can be various sizes or designed to hold various volumes of liquid or amounts of solid material.
  • the dropper tube can include measurement delineations or marks on the tube to allow the user to measure certain amounts of components to be added to the tube or to track an amount of sample added.
  • the kit can include more than one dropper tube 110 and dropper cap 115.
  • FIG. 2 illustrates a perspective view of the testing container 120 shown in FIG. 1.
  • a sample volume (220, 230, 240) from the dropper tube 110 can be dispensed into each well of the testing container 120, such as wells Bl through Bn, using either a dropper tube 110 with a fitted dropper cap 115, a transfer pipette, or any other suitable pipetting or transfer technique (FIG. 6).
  • the sample mixture is dispensed as a droplet.
  • the volume of the sample mixture dispensed into each of the wells of the testing container is a volume amount that is effective for testing the presence or absence of the one or more health conditions.
  • the volume of sample mixture dispensed into each well of the testing container ranges from 5 pl to 80 pl (e.g., such as 10 pl to 30 pl, 30 pl to 60 pl, 20 pl to 70 pl, 20 pl to 60 pl, 30 pl to 80 pl, 30 pl to 70 pl, and the like).
  • the volume of the sample mixture dispensed into each well is 5 pl or more, 10 pl or more, 15 pl or more, 20 pl or more, 25 pl or more, 30 pl or more, 35 pl or more, 40 pl or more, 45 pl or more, 50 pl or more, 55 pl or more, 60 pl or more, 65 pl or more, 70 pl or more, 75 pl or more, or 80 pl or more.
  • the wells in the testing container 120 can each contain buffers or other reagents, including small molecule or chemical reagents, large molecule reagents (e.g., aptamers, enzymes, antibodies, DNA, RNA, oligonucleotides, primers, probes, labels, tags, antibodies, molecular beacons, etc.).
  • buffers or other reagents including small molecule or chemical reagents, large molecule reagents (e.g., aptamers, enzymes, antibodies, DNA, RNA, oligonucleotides, primers, probes, labels, tags, antibodies, molecular beacons, etc.).
  • there are different buffer solutions or reagents in each well may include one or more buffer solutions or other reagents specific to a particular health condition (e.g., a first health condition, a second health condition, a third health condition etc.) for which a subject or user is being tested.
  • the subject might be tested for two or more different sexually transmitted infections (STIs), or might be tested for pregnancy in addition to one or more STIs.
  • the wells could be specific to different fertility tests including testing for levels of progesterone or estrogen, or there can be a combination of any of the above in a single testing container with each well being specific to a different health condition.
  • the extraction buffer e.g., Buffer A
  • the extraction buffer is the same as one or more buffers in one or more wells (e.g., Buffer B) of the testing container.
  • the extraction buffer e.g., Buffer A
  • the extraction buffer is different from one or more buffers (e.g. Buffer B) in the one or more wells.
  • the buffer in the extraction container comprises one or more buffers selected from: sodium hydroxide, potassium hydroxide, sodium chloride, potassium chloride, sulfuric acid, nitric acid, hydrochloric acid, PBS (phosphate buffered saline), TBS (Tris buffered saline), tricine, and/or HBS (HEPES buffered saline), 3-[(3- Cholamidopropyl) dimethylammonio]-l -propanesulfonate BugBusterTM, octylthioglucoside, Triton X-100, and octyl glucoside.
  • buffers selected from: sodium hydroxide, potassium hydroxide, sodium chloride, potassium chloride, sulfuric acid, nitric acid, hydrochloric acid, PBS (phosphate buffered saline), TBS (Tris buffered saline), tricine, and/or HBS (HEPES buffered saline), 3-[(
  • the extraction container, testing container e.g. one or more wells of the testing container
  • the extraction container and testing container comprises a buffer with a protein component such as , but not limited to: chicken albumin, 0.001%-l% casein or 0.001%-l% bovine albumin.
  • the buffer may contain a crowding agent such as 0. l%-10% 1000-100000 dextran or 3500-20000 polyethylene glycol or Polyamines or aminoacids.
  • the buffer may contain a non-ionic surfactant like Tergitol, Tween-20, CHAPS, TAPSO or detergents like OTG.
  • the buffer may contain an antibacterial agent as thimerosal, 0.01%-l% proclin-300 or sodium azide, phosphate buffered saline, Tris- 45 buffered saline,
  • HEPES 4-(2-hy droxy ethyl)- 1 -piperazineethanesulfonic acid
  • an extraction substance comprising one or more of: 3-[(3-Cholamidopropyl) dimethylammonio]- 1- propanesulfonate, a protein extraction reagent, octyl- 50 thioglucoside, sodium hydroxide, Triton X-100, or octyl glucoside.
  • the buffer in the extraction container, the testing container (e.g. one or more wells of the testing container), or both the extraction container and testing container can include one or more buffers selected from: 5-500mM sodium hydroxide, 5- 500mM potassium hydroxide, 1-2000 mM sodium chloride, 1-2000 mM potassium chloride,
  • 5-500mM sulfuric acid or 5-500mM nitric acid or 5-500mM hydrochloric acid 1-50 % PBS (phosphate buffered saline), 1-50 % TBS (Tris buffered saline), 1-50% tricine, 1-50% HBS (HEPES buffered saline), 00.1%-10% 3-[(3-Cholamidopropyl) dimethylammonio]-l- propanesulfonate, 0. l%-10% BugBusterTM, 0.01%-10% octylthioglucoside, 0.01%-10% Triton X-100, and 0.01%-10% octyl glucoside.
  • the extraction buffer is selected from one or more of: 5- 500mM sodium hydroxide, 5-500mM potassium hydroxide, 1-2000 mM sodium chloride, 1- 2000 mM potassium chloride, 5-500mM sulfuric acid or 5-500mM nitric acid or 5-500mM hydrochloric acid, 1-50 % PBS (phosphate buffered saline), 1-50 % TBS (Tris buffered saline), 1-50% tricine, and/or 1-50% HBS (HEPES buffered saline).
  • PBS phosphate buffered saline
  • TBS Tris buffered saline
  • HBS HBS buffered saline
  • Extraction substances including, but not limited to: 00.1%-10% 3-[(3-Cholamidopropyl) dimethylammonio]-l- propanesulfonate, 0.1%- 10% BugBusterTM, 0.01%-10% octylthioglucoside, 0.01%-10% Triton X-100, and 0.01%-10% octyl glucoside
  • one or more wells of the testing container includes one or more buffers selected from: 5-500mM sodium hydroxide, 5-500mM potassium hydroxide, 1- 2000 mM sodium chloride, 1-2000 mM potassium chloride, 5-500mM sulfuric acid or 5- 500mM nitric acid or 5-500mM hydrochloric acid, 1-50 % PBS (phosphate buffered saline), 1-50 % TBS (Tris buffered saline), 1-50% tricine, 1-50% HBS (HEPES buffered saline), 00.1%-10% 3-[(3-Cholamidopropyl) dimethylammonio]-l-propanesulfonate, 0. l%-10% BugBusterTM, 0.01%-10% octylthioglucoside, 0.01%-10% Triton X-100, and 0.01%-10% octyl glucoside.
  • buffers selected from: 5-500mM sodium hydroxide, 5-500m
  • buffer B in a well of the testing container may comprise of a substance that is selected from one or more: 1-50 % PBS (phosphate buffered saline), 1-50 % TBS (Tris buffered saline), 1-50% tricine, and/or 1-50% HBS (HEPES buffered saline).
  • Buffer B may also contain an extraction substance including, but not limited to: 00.1 %- 10%
  • the buffer in the extraction container, the buffer in the testing container, or the buffer in the extraction container and the testing container comprises one or more buffers selected from: sodium hydroxide, potassium hydroxide, sodium chloride, potassium chloride, sulfuric acid, nitric acid, hydrochloric acid, PBS (phosphate buffered saline), TBS (Tris buffered saline), tricine, and/or HBS (HEPES buffered saline), 3-[(3- Cholamidopropyl) dimethylammonio]-l -propanesulfonate BugBusterTM, octylthioglucoside, Triton X-100, octyl glucoside, chicken albumin, casein, bovine albumin, 1000-100000 dextran, 3500-20000 polyethylene glycol, Polyamines, amino acids, Tergitol, Tween-20, CHAPS, TAPSO, OTG, an antibacterial agent as thimerosal
  • the extraction container, testing container e.g. one or more wells of the testing container
  • the extraction container and testing container comprises a buffer with a protein component such as, but not limited to: chicken albumin, 0.001%-l% casein or 0.001%-l% bovine albumin.
  • the buffer may contain a crowding agent such as 0. l%-10% 1000-100000 dextran or 3500-20000 polyethylene glycol or Polyamines or aminoacids.
  • the buffer may contain a non-ionic surfactant like Tergitol, Tween-20, CHAPS, TAPSO or detergents like OTG.
  • the buffer may contain an antibacterial agent as thimerosal, 0.01%-l% proclin-300 or sodium azide, phosphate buffered saline, Tris- 45 buffered saline,
  • HEPES 4-(2-hy droxy ethyl)- 1 -piperazineethanesulfonic acid
  • an extraction substance comprising one or more of: 3-[(3-Cholamidopropyl) dimethylammonio]- 1- propanesulfonate, a protein extraction reagent, octyl- 50 thioglucoside, sodium hydroxide, Triton X-100, or octyl glucoside, 1-2000 mM sodium chloride or 1-2000 mM potassium chloride, chicken albumin, 0.001%-l% casein, 0.001%-l% bovine albumin, 0.1%- 10% 1000- 100000 dextran or 3500-20000 polyethylene glycol, Polyamines, amino acids, a non-ionic surfactant like Tergitol, 0.
  • buffer B in a well of the testing container may also contain salt components, such as 1-2000 mM sodium chloride or 1-2000 mM potassium chloride.
  • buffer B may contain a protein component such as chicken albumin, 0.001%- 1% casein or 0.001%-l% bovine albumin.
  • buffer B may contain a crowding agent such as 0. l%-10% 1000-100000 dextran or 3500-20000 polyethylene glycol or Polyamines or amino acids.
  • buffer B may contain a non-ionic surfactant like Tergitol, 0. l%-5% TweePn-20, 0. l%-5% CHAPS, 0. l%-5% TAPSO or detergents like OTG.
  • buffer B may contain an antibacterial agent as thimerosal, 0.01%-l% proclin-300 or sodium azide.
  • Buffer A, Buffer B, or Buffer A and Buffer B in a well of the testing container may also contain salt components, such as 1-2000 mM sodium chloride or 1-2000 mM potassium chloride.
  • Buffer A, Buffer B, or Buffer A and Buffer B may contain a protein component such as chicken albumin, 0.001%-l% casein or 0.001%-l% bovine albumin.
  • Buffer A, Buffer B, or Buffer A and Buffer B may contain a crowding agent such as 0.1 %- 10% 1000-100000 dextran or 3500- 20000 polyethylene glycol or Polyamines or amino acids.
  • Buffer A, Buffer B, or Buffer A and Buffer B may contain a non-ionic surfactant like Tergitol, 0.1%- 5% TweePn-20, 0. l%-5% CHAPS, 0. l%-5% TAPSO or detergents like OTG.
  • Buffer A, Buffer B, or Buffer A and Buffer B may contain an antibacterial agent as thimerosal, 0.01%-l% proclin-300 or sodium azide.
  • the volume of buffer in each well can range from 50 pl to about 150 pl (e.g., 50 pl to 70 pl, 60 pl 100 pl, 70 pl to 100 pl, 70 pl to 120 pl, 80 to 120 pl, 90 pl to 120 pl, 100 pl to 110 pl, 110 pl to 120 pl).
  • the volume of buffer in each well is 70 pl or more, 75 pl or more, 80 pl or more, 85 pl or more, 90 pl or more, 95 pl or more, 100 pl or more, 105 pl or more, 110 pl or more, 115 pl or more, or 120 pl or more.
  • the testing container 120 is designed to scale based on the number of test strips that need to be evaluated and can be personalized for the assay to be as sensitive and specific without compromising or interfering with the other test strips. For example, if 3 health conditions are to be tested for, then the testing container can include 3 wells for each of the health conditions tested for, and the signal output device can include 3 test strips for placement into each respective well.
  • the size configuration of the wells is designed to house the specific volume of buffer in the wells. Additionally, in some embodiments, the diameter and height of the well is also designed to allow each test strip to be lowered into each well such that the target sample mixture (sample mixture containing the target material mixed with buffer within the well) is in fluid communication with an end of the strip.
  • the testing container may be constructed of various different materials, including plastic, rubber, glass, metal, etc. It may be disposable or it can be washed and reused in some designs.
  • the testing container shown in the figure includes three wells, but it can alternatively include one or two wells, or it can include numbers above three (four, five, six, seven, eight, nine, ten, fifteen, twenty, or more). In some examples, it can be a sample plate or micro-well plate with numerous wells.
  • the testing container is designed to have a base portion 180 (FIG. 2) or stand at the bottom that allows the testing container to sit on a surface.
  • the bottom of the stand is flat to allow it to sit stably.
  • the upper portion of the testing container 190 of FIG. 2 with the wells (150, 160, 170) can be smaller in size (smaller length, or width, or diameter) to allow a housing of the signal output device 130 to be placed over and surround the upper portion 190 of the testing container.
  • the mixing step may be further fulfilled by the stirrer 125 in the test kit (FIG. 7) provided or by beads in either buffer A or buffer B wells or a shaker (e.g., if used in a lab) or various other mixing components.
  • the stirrer 125 illustrated in the figure includes more than one prong attached to a handle.
  • the prongs or arms are numbered to match the number of wells in the testing container so that the stirrer can stir all the wells simultaneously with one prong or arm in each well. For example, if there are 2 wells in the testing container, the stirrer can include two prongs or arms, one for each well. In another example, if there are 3 wells in the testing container, the stirrer can include three prongs or arms, one for each well.
  • FIGS. 3-4 illustrate various views of the signal output device 130 shown in FIG.
  • FIG. 3 illustrates perspective views of the signal output device 130
  • FIG. 4A illustrates a cross-sectional view of the signal output device 130
  • FIG. 4B and FIG. 4C illustrate two halves of the device separated to show the internal structure, with FIG. 4B showing a view of the internal surface of the back of the device, and FIG. 4C showing the internal surface of the front of the device.
  • the signal output device 130 includes one or more testing devices or test strips, such as test strip 135, that are each designed to identify a status of a health condition.
  • the number of test strips included in a signal output device 130 may vary.
  • the signal output device 130 may include one test strip, two test strips, three test strips, or the like.
  • each test strip 135 may be independently optimized and designed for a particular health condition
  • the signal output device 130 may include test strips for a variety of health conditions, such as infectious diseases caused by bacterial, viral, and/or parasitic agents, health conditions relating to pregnancy and/or fertility, or the like.
  • each test strip 135 is designed to work independently to prevent interference from other test strips that may also be located on the signal output device 130.
  • the signal output device 130 includes a housing that contains the test strips.
  • the housing completely or partially surrounds the test strips.
  • the housing 250 is sized to fit over the upper portion 190 of the testing container to surround the upper portion 190 and allow one end of each of the test strips 135 to be lowered into a corresponding well (150, 160, 170) of the testing container so that one end of each test strip 135 is in contact with the solution (e.g., sample mixed with one or more buffers or other reagents) in one of the wells.
  • the solution e.g., sample mixed with one or more buffers or other reagents
  • each strip that will be in fluid communication with the well will include the end of the strip with a loading zone 8 (FIG.4D) that is in fluid communication with the buffers and/or reagents and sample mixture in each respective well of the testing container.
  • a loading zone 8 FIG.4D
  • Other designs can also be used where the signal output device does not surround a portion of the testing container, including a design where the housing sits on top of the testing container but is spring loaded to allow the user to press a button or otherwise manipulate the device to cause the strips to be moved downward into the wells.
  • the upper part 260 of the housing is closed and is smaller relative to the lower part 270 for easy gripping by the user.
  • Other handheld designs can be used, as well, and the housing can take different shapes (square, rectangular, circular).
  • the housing can include one or more windows or apertures 210 for viewing the test strips and reading the results of the test. There can be a single larger window or multiple windows, one for each strip.
  • the test is a digital test that reads the test strips and presents the results for each test on one or more digital screens.
  • the side view shown in FIG. 4 illustrates how the test strips individually sit within the device.
  • the device is disposable after use.
  • the user can purchase additional test strips and additional buffers/reagents to reuse the kit.
  • the user can open the signal output device to replace the test strips with new ones.
  • the test strips can act as lateral flow assays that draw liquid up from the wells of the testing container.
  • the test strips are positioned so that they are spaced apart and liquid does not cross between the two. This design of the test strips and the design of the testing container with different wells allow the user to easily take a single sample in one container but run multiple different lateral flow assays on it with each well having the necessary components specific to the particular assay.
  • test strips contained in a single housing as shown in FIGs. 4A and 4D allows for easy run of multiple assays without the user having to manage multiple different strips manually, and it provides for easy readability.
  • the configuration of the housing shell or encasing is shown in FIGs. 4B-4C.
  • FIG. 4A shows a cross section of the device from top to bottom of the device, according to an embodiment. This view illustrates two test strips sitting within the device and secured in place by multiple structures on the device.
  • the front portion 280 of the device (upper portion in figure) includes a lip 215 at the upper most (or left most in the figure) position on the device. This lip 215 mates with the lip 285 on the back portion 290 (or lower portion in figure) of the device.
  • the lip 285 sits between the lip 215 and the upper elongated rib 205 to allow a mating to occur to assist in holding the front and back of the shell together.
  • These portions 205 215, 275, and 285 can continue around the edge of the entire device where the front and back portions meet, or these can continue along only a portion of the device.
  • pegs or wedges or pressure points
  • the viewing windows have a lip 245 around the edge of the window that further rest on each strip to secure the strip in place.
  • On the back 290 of the housing there is a peg 255 and an elongated rib 265 that additional help to secure the strips in place.
  • Peg 225 holds the strip against the curvature of the back internal surface of the housing so that the upper portion of the strip is secured.
  • the back surface of the housing curves inward at the top of the device and curves outward at the bottom of the device, such that the upper portion of the device has a smaller cross section from front to back than the lower portion of the device.
  • the device tapers to a lower cross section from bottom to top of the device.
  • Peg 225 sits on the back surface of the device opposite the uppermost lip 245 of the viewing window on the front surface, and these two parts 225 and 245 hold the strip in between securely in place.
  • the elongated rib 265 on the back surface sits opposite the lower elongated rib 248 on the front surface to hold the strips in between at the lower end of the device. Thus, the lower portion of the strip is also secured.
  • the pegs 235, 246, and rounded peg 247 rest on or near the strip to also help secure the strip in place from the front surface without a matching peg opposite them on the back surface.
  • FIG. 4B and FIG. 4C illustrate two halves of the device separated to show the internal structure, with FIG. 4B showing a view of the internal surface of the back 290 of the device, and FIG. 4C showing the internal surface of the front 280 of the device.
  • FIG. 4B shows the peg 255 and the elongated rib 265 that help to hold the strip in place, along with the lip 285 and the divot 275 for mating to the front half of the housing.
  • FIG. 4C illustrates all of the various pegs for holding the strips in place. There is shown the upper peg 225 to hold the upper portion of the strip in place, and in the example of FIG.
  • pegs 225 there are three such pegs 225 for each of the three strips that can be held in this embodiment. For other designs with more or fewer strips, there will be more or fewer pegs. There is also shown the middle peg 235, again including three pegs 235 for holding the strip in place. There are also the lower pegs 246, including three such pegs 246, for holding the strip in place.
  • the round pegs 247 are shown above and below the viewing window, with two round pegs 247 adjacent pegs 235, and two round pegs 247 adjacent pegs 246. There are also two round pegs 247 near the lower elongated rib 248. In the figure.
  • the lower elongated rib 248 is shown as having two lips or edges with a groove in between.
  • the figure also shows the upper elongated rib 205 and the lip 215.
  • FIGS. 4A-4C illustrate just one possible arrangement.
  • the housing is molded as a single unit instead of two halves, and the strips are slid into the unit from above or below.
  • the housing has more than two pieces that mate.
  • FIG. 4D provides various components of the signal output device.
  • FIG. 4D provides the front housing shell 280, the test strips 1, 2, and 3, the back housing shell 290 containing wedges, pegs, and/or pressure points for housing the test strips and configuring the fluid mechanics for use when the test strips come in contact with a solution (e.g., first target sample solution, second target sample solution, third target sample solution, etc.) within the wells (e.g., at least a first and second well).
  • a solution e.g., first target sample solution, second target sample solution, third target sample solution, etc.
  • the back housing shell 290 shows the regions within the housing where the test strips will be located, e.g., in a fitted wedge that holds the test strips in place.
  • FIG. 4D also provides a non-limiting example of how the one or more test strips are disposed into their respective wells of an exemplary testing container. As shown in this non-limiting example, none of the wells of the testing container are fluidically connected.
  • FIG. 4E provides a schematic diagram of the main cassette or housing of the signal output device 130.
  • the housing includes a front shell 280 and back shell 290, with test strips 1, 2, and 3 placed between the front 280 and back 290 shells.
  • the front part 280 of the cassette or housing has three windows 210 to view results of the tests after completion of the test performed by a user (e.g., indication status).
  • the back part 290 of the cassette or housing has three chambers for housing or holding, in this example, three test strips. Each chamber has a wedge mechanism in place configured to hold the strip in place within the chamber and prevents movement of the strip.
  • the strip control and test lines align to the windows in the front region 280 of the cassette or housing.
  • the pressure points within the housing will provide additional support to the strip and components.
  • the cassette or housing has a bottom skirt that fits only in one direction on the base (3 well stand) in FIG. 2. This helps align the strips and chemistry to the specific positions on the strip and wells.
  • each test strip 135 includes one or more of a loading zone 8, a reaction zone 7, a testing zone 6, and/or a control zone 5.
  • Test strips that can be used in the signal output device of the present system and methods can be found in U.S. Patent No.: 10,794,911, which is hereby incorporated by reference in its entirety.
  • the loading zone 8, the reaction zone 7, the testing zone 6, and the control zone 5 are fluidly coupled.
  • adjacent zones can overlap; however, in other embodiments, one or more adjacent zones of the signal output device 130 may not overlap.
  • FIG. 4E provides a schematic diagram of the signal output device along with exemplary dimensions.
  • the sampling kit includes a process mode where, in the process mode, the sample output device 130 is placed over the testing container, and, once securely locked into or lowered into the testing container, the loading zone for each test strip can be in fluid communication with the buffers and/or reagents and sample mixture in each respective well of the testing container, and a sample generated upon extraction of an agent by the extraction buffer (e.g. sample mixture) flows against gravity through the loading zone, the reaction zone, the testing zone, and the control zone.
  • the retained orientation of the device thus positions the testing container vertically, such that the sample flows against gravity.
  • the retained orientation can be a non-vertical orientation (e.g. horizontal).
  • the signal output device of the present disclosure includes at least a first strip and a second strip.
  • the signal output device comprises at least one strip. In some embodiments, the signal output device comprises at least two strips, at least three strips, at least four strips, at least five strips, at least six strips, at least seven strips, at least eight strips, at least nine strips, or at least ten strips. [00123] In some embodiments, each of the strips are placed in a fitted wedge of the housing of the signal output device that holds the strips in place. The configuration of the housing allows for each individual test strip to be in separate chambers, and not fluidically connected. In some embodiments, there are pressure points in the signal output device at multiple locations that keep the strip components in place. Additionally, the pressure points on the strips help hold and maintain flow of buffers throughout the strip until the strip is saturated.
  • the loading zone is located 8 at a distal end of the test strip 135 and is insertable into the testing container 120. When received by the loading zone, the target material flows to the reaction zone 7.
  • the loading zone can include or be composed of cellulose and/or glass fiber.
  • the loading zone 8 is capable of transporting the sample to other parts of the test strip 135 (e.g., by way of fluid coupling).
  • each of the wells of the testing container can include a volume of the target sample solution ranging from 70 pl to 120 pl.
  • the loading zone may be configured to receive a target sample solution of varying volumes, where in some instances the sample zone is configured to receive a sample having a volume ranging from 0.1 pl to 120 pl, such as 5 pl to 20 pl, such as 1 pl to 3 pl, such as 1 pl to 5 pl, such as 1 pl to 10 pl, such as 10 pl to 20 pl, such as 20 pl to 1200 pl, such as 30 pl to 1200 pl, and the like.
  • the sample zone is configured to receive a sample having a volume of at least 0.1 pl, at least 0.5 pl, at least 1 pl, at least 5 pl, at least 10 pl, at least 15 pl, at least 20 pl, at least 25 pl, at least 30 pl, at least 35 pl, at least 40 pl, at least 45 pl, at least 50 pl, at least 55 pl, at least 60 pl, at least 65 pl, at least 70 pl, at least 75 pl, at least 80 pl, at least 85 pl, at least 90 pl, at least 95 pl, at least 100 pl, at least 105 pl, at least 110 pl, at least 115 pl, or at least 120 pl.
  • the transportation of the sample through different zones from the loading zone is in a continuous and/or homogenous manner.
  • the loading zone includes materials or reagents that pretreat the sample before its transportation.
  • the loading zone includes pretreating materials/reagents configured for one or more of separation of sample components, removal of interfering materials, and/or adjustment of pH.
  • the extraction buffer upon contacting a sample from the subject, is configured to extract target materials associated with the health condition(s) of interest.
  • Target materials can be associated with different regions of the same or different agents (e.g., infectious agents).
  • the signal output device comprising at least a first strip and a second strip can include substrate materials and/or structures that provide for lateral flow of a sample from a loading zone to a testing zone.
  • the strip includes a bibulous material or member that readily absorbs liquid and provides for liquid flow through the member.
  • bibulous materials include: organic or inorganic polymers and natural and synthetic polymers. More specific examples of suitable solid supports include, without limitation, glass fiber, cellulose, nylon, cross-linked dextran, various chromatographic papers and nitrocellulose.
  • the bibulous member includes a membrane, and in a specific example, the membrane is a nitrocellulose membrane. In some embodiments, the membrane is located in testing zone and/or control line zone, described in more detail below.
  • the bibulous member and overall configuration of a lateral flow assay device implemented in embodiments of the system may vary, in certain embodiments the bibulous member can have a strip configuration, some embodiments of which are described in U.S. Patent No.: 10,794,911, which is hereby incorporated by reference in its entirety. Where the bibulous material is configured as a strip, the bibulous member can have a length that is longer than its width. In some examples, the length is longer than the width by 1.5 fold or more, such as 2-fold or more, e.g., 10 fold or more, including 20-fold or more.
  • the length of the bibulous member ranges from 0.5 to 20 cm, such as 1.0 to 15 cm, e.g., 2.0 to 10 cm, while the width ranges 0.1 to 10.0 cm, such as 0.5 to 2.5 cm, e.g., 1 to 2 cm.
  • the thickness of the bibulous member may also vary, ranging in some instances from 0.01 to 0.05 cm, such as 0.1 to 0.4 cm, e.g., 0.1 to 0.25 cm.
  • the signal output device can include an absorbent pad downstream from the reaction zone and any control region, e.g., at the end distal from the sample loading zone, where the absorbent pad is configured to absorb fluid and reagents present therein that have flowed through the bibulous member. While the configuration of the absorbent pad may vary, in some instances it is configured to absorb a volume of liquid that is substantially the same as the volume of sample that is applied to the sample loading zone during use.
  • the signal output device can include a sample pad. In some embodiments, the signal output device can include a backing card. In some embodiments, the signal output device can include a membrane. In some embodiments, at least one strip of the signal output device can include one or more of an absorbent pad, a conjugate release pad, a wicking pad, a test line, a control line, a sample pad, and a backing card. In some embodiments, the signal output device can include a sample pad. In some embodiments, the signal output device can include a backing card.
  • At least one strip of the signal output device can include one or more of an absorbent pad, a conjugate release pad, a wicking pad, a test line, a control line, a membrane, a sample pad, and a backing card.
  • embodiments of the loading zone can include a terminal zone (e.g., a most upstream zone) of the bibulous member, e.g., positioned closer to one end of the bibulous member.
  • embodiments of the loading zone may be distinct from the bibulous member, but configured to provide for fluid communication of sample into the bibulous member upon application of sample to the sample loading zone.
  • the loading zone may be configured to receive samples of varying volumes, where in some instances the sample zone is configured to receive a sample having a volume ranging from O.lul to 20ml such as 5ul to 20 ml.
  • the loading zone may include a metering device configured to meter a specific amount of sample into the bibulous member.
  • the reaction zone is fluidly coupled to the loading zone and includes one or more reaction substances, such as one or more reaction substances listed in TABLE 1, TABLE 2, and/or TABLE 3.
  • the one or more reaction substances may be conjugated to labels that are configured to enable detection of a target material associated with the health condition.
  • the target material flows to the reaction zone 7, where the reaction zone 7 includes a first reaction substance conjugated to a first label, wherein the first reaction substance preferentially couples to a first target of target material.
  • the reaction zone can optionally include a second reaction substance conjugated to a second label, where the second reaction substance preferentially couples to a second target of a target material.
  • the first reaction substance and the second reaction substance are not immobilized within the reaction zone.
  • the reaction zone can include more than two reaction substances conjugated to respective labels, in relation to assays performed on different types of target material (e.g., related to different health conditions).
  • the reaction zone only includes one reaction substance conjugated to a label, wherein the reaction substance couples to a target of a target material.
  • Embodiments of the reaction zone can be positioned at some distance downstream from the loading zone.
  • the distance between the loading zone and the reaction zone may vary. In some embodiments, the distance ranges from 0.1 to 10 cm, such as 0.1 to 3 cm and including 0.5 to 2 cm.
  • the reaction zone overlaps with the loading zone in a portion or full. In some embodiments, the reaction zone overlaps with the loading zone in about 25%, 50%, 75%, and 100%.
  • the reaction substances implemented for detection are not immobilized at the reaction zone(s).
  • a substance and the bibulous member maintain their position relative to each other in space under the conditions of use, e.g., under the assay conditions.
  • a not immobilized reaction substance is not stably associated with the bibulous member and can migrate under the capillary pressure or other drivers of sample flow.
  • a reaction substance binds to a specific region of a target material of a pathogen or other agent.
  • the reaction zone includes two or more reaction substances that are conjugated to the same or different labels. In some embodiments, the two or more reaction substances are not immobilized. In some embodiments, the two or more substances each bind to the same specific region of the same target material of an agent or biomarker. In some embodiments, the two or more substances each bind to two or more different specific regions of the same target material of an agent or biomarker. In some embodiments, the two or more substances each bind to a specific region of two or more different target materials of an agent or biomarker. In some embodiments, the two or more substances each bind to a specific region of target materials of two or more different agents or biomarkers.
  • reaction substances in the reaction zone that bind to specific agent/biomarker regions of target material of interest can include one or more of: a protein, a peptide or its analogs (e.g., an antibody, antigen, peptoid, D-peptide, beta-peptide), or a nucleic acid (e.g., an aptamer) or its analogs.
  • a protein e.g., an antibody, antigen, peptoid, D-peptide, beta-peptide
  • a nucleic acid e.g., an aptamer
  • the reaction substances each bind to one or more specific regions of target material of different pathogens or biomarkers (e.g., of sexual health).
  • the reaction zone can include non-immobilized aptamers and/or antibodies listed in TABLE 1, TABLE 2, and/or TABLE 3, such that a sample that has undergone extraction can flow through the reaction zone and individual units of target material associated with each health condition can bind with their respective reaction substances before flowing to the testing zone.
  • the reaction substance that binds to a specific region of an agent is an aptamer or aptamers.
  • the aptamer is generated by an in vitro process known as SELEX (systematic evolution of ligands by exponential enrichment).
  • the aptamer is an organic molecule.
  • the aptamer has a molecular weight of about 50 to 100 Da, 50 to 200 Da, 50 to 500 Da, 50 to 1000 Da, 50 to 2,000 Da, 50 to 3,000 Da, 50 to 4,000 Da, 50 to 5,000 Da, 50 to 6,000 Da, 50 to 7,000 Da, 50 to 8,000 Da, 50 to 9,000 Da, 50 to 10,000 Da, 50 to 11,000 Da, 50 to 12,500 Da, 50 to 15,000 Da, 100 to 200 Da, 100 to 500 Da, 100 to 1000 Da, 100 to 2,000 Da, 100 to 3,000 Da, 100 to 4,000 Da, 100 to 5,000 Da, 100 to 6,000 Da, 100 to 7,000 Da, 100 to 8,000 Da, 100 to 9,000 Da, 100 to 10,000 Da, 100 to 11,000 Da, 100 to 12,500 Da, 100 to 15,000 Da, 200 Da to 500 Da, 200 to 1000 Da, 200 to 2,000 Da, 200 to 3,000 Da, 200 to 4,000 Da, 200 to 5,000 Da, 200 to 6,000 Da, 200 to 7,000 Da, 200 to 8,000 Da, 200 to 8,000 Da, 200 to 5,000
  • the reaction zone includes reaction substances including aptamers listed in TABLES 1, 2, and 3.
  • the reaction substance that binds to a specific region of an agent includes a molecular beacon or molecular beacons.
  • Molecular beacons are a specific DNA hairpin structure with fluorophore at one end and quencher at the other end.
  • the molecular beacon binds to a target substance of a pathogen, wherein the target substance comprises a nucleic acid, a toxin, and/or a protein or peptide.
  • the molecular beacon comprises a loop region and/or a double stranded stem region.
  • the loop region is complementary to a target substance (e.g., a DNA, an mRNA, a toxin or a protein of a pathogen).
  • the molecular beacon has about 10 to 15, 10 to 20, 10 to 25, 10 to 30, 10 to 35, 10 to 40, 10 to 45, 10 to 50, 15 to 20, 15 to 25, 15 to 30, 15 to 35, 15 to
  • the molecular beacon has about 15 to 30 base pairs in the loop, wherein the loop is complimentary to a target substance.
  • the molecular beacon has about 3 to 4, 3 to 5, 3 to 6, 3 to 7, 3 to 8, 3 to 9, 4 to 5, 4 to 6, 4 to 7, 4 to 8, 4 to 9, 5 to 6, 5 to 7, 5 to 8, 5 to 9, 6 to 7, 6 to 8, 6 to 9, 7 to 8, 7 to 9 or 8 to 9 base pairs at the double stranded stem region.
  • the reaction substance that binds to a specific region of a pathogen includes a DNA probe.
  • the reaction substances include antibodies.
  • an antibody used is a monoclonal antibody.
  • the antibody is a polyclonal antibody.
  • the antibody is a bispecific antibody that binds to two separate regions of an agent, or two separate regions of two different agents.
  • the substance is a fragment or a variant of an antibody (e.g., Fab fragment or single chain variable fragment).
  • the reaction substances include monoclonal antibodies that bind to a specific region of target substance on an agent (e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Gardnerella vaginitis, Mycoplasma genitalium, estrogen, progesterone, testosterone, anti -mull eri an hormone, follicle-stimulating hormone, luteinizing hormone, estradiol, thyroid-stimulating hormone, free thyroxine, prolactin, Candida Albicans (yeast infection), Human immunodeficiency virus (HIV), Human papillomavirus (HPV), Hepatitis C virus (HCV), Hepatitis B virus (HBV), Herpes simplex virus (HSV)).
  • an agent e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomon
  • monoclonal antibodies can be generated using a hybridoma technique.
  • monoclonal antibodies can be produced from a single B- lymphocyte clone involving immunizing a certain species (e.g., a mouse, rat, rabbit, or goat) against the specific region on a target substance and obtaining the B-lymphocytes from the spleen of the species.
  • the B-lymphocytes are then fused (by chemical- or virus- induced methods) with an immortal myeloma cell line lacking the hypoxanthine-guanine- phosphoribosyltransferase (HGPRT) gene and not containing any other immunoglobulin- producing cell.
  • HGPRT hypoxanthine-guanine- phosphoribosyltransferase
  • hybridoma cells are then cultured in vitro in selective medium (i.e. medium containing hypoxanthine-aminopterinthymidine) where only the hybridomas (i.e. the fusion between the primary B-lymphocytes and myeloma cells) survive as they have inherited immortality from the myeloma cells and selective resistance from the primary B-lymphocytes (as the myeloma cells lack HGPRT, they cannot synthesize nucleotides de novo as this is inhibited by aminopterin in the selective medium).
  • selective medium i.e. medium containing hypoxanthine-aminopterinthymidine
  • the initial culture of hybridomas contains a mixture of antibodies derived from many different primary B-lymphocyte clones, each secreting its own individual specific antibody into the culture medium (i.e.
  • the antibodies are still polyclonal). Each individual clone can be separated by dilution into different culture wells. The cell culture medium can then be screened from many hundreds of different wells for the specific antibody activity required and the desired B-lymphocytes grown from the positive wells and then recloned and retested for activity. The positive hybridomas and monoclonal antibodies generated can then be stored away in liquid nitrogen.
  • Monoclonal antibodies can also be generated using phage display. This involves isolating B-lymphocytes from the blood of humans and then isolating the mRNA and converting it into cDNA using PCR to amplify all the VH and VL segments. These segments can then be cloned into a vector (usually as scFv) next to the Pill protein of a bacteriophage. This vector is then introduced into E. coli cells in order to generate a library containing approximately 10 10 clones of antibody fragments. E. coli can then secrete the bacteriophage containing the VH and VL segments as part of the bacteriophage coat.
  • a vector usually as scFv
  • VH and VL segments against the target substance can then be selected and used to re-infect E. coli with the bacteriophage. Cells containing the plasmid can then be isolated and sequenced. Its advantages include: once the library is made, the same library can be used to generate new antibodies and does not have to be remade, no immunizations are required as the entire process is done in vitro, antibodies can be obtained much more quickly than the traditional hybridoma technique and the library can be used to generate antibodies to toxic target substances that could not be used to immunize an animal.
  • monoclonal antibodies can also be improved in multiple aspects.
  • binding affinity to the target substance can be improved by using phage display libraries to isolate antibodies with strong affinities for the target substance.
  • monoclonal antibodies are recovered and/or purified with a process comprising one or more of the following steps: 1) harvest antibodies with centrifugation/filtration thereby removing cells and cell debris; 2) protein A and/or protein G chromatograph which yields highly purified product in a single step; 3) low pH hold to inactivate endogenous/adventitious viruses; 4) additional chromatography stepsto further remove impurities and viruses; 5) filtration to further remove endogenous/adventitious viruses; and 6) ultrafiltration/diafiltration.
  • the reaction zone includes reaction substances including antibodies listed in TABLES 1, 2, and 3.
  • the reaction zone further includes a substance that binds to a biomarker of pregnancy.
  • the biomarker(s) include one or more of human chorionic gonadotropin (hCG), activin A, pregnancy-associated plasma protein-A (PAPP-A), human placental lactogen (hPL), A disintegrin and Metalloprotease- 12 (ADAM-12), pregnancy-specific beta glycoprotein 1 (SP- 1), placental mRNAs, progestrerone, Inhibin A, Vascular Endothelial Growth Factor (VEGF), Placental-like growth factor (P1GF), Leukemic Inhibitory Factor, Glycodelin, Mucin-1, Adrenomedullin, and other biomarkers.
  • hCG human chorionic gonadotropin
  • PAPP-A pregnancy-associated plasma protein-A
  • hPL human placental lactogen
  • ADAM-12 A disintegrin and Metalloprotease- 12
  • SP- 1 pregnancy-specific beta glycoprotein 1
  • the reaction zone further includes a substance that binds to a biomarker of fertility.
  • the biomarker(s) include one or more of oestrone-3 -glucuronide (E3G0, luteinizing hormone, follicle stimulating hormone (FSH), estrogen, progesterone, testosterone, anti-mullerian hormone, follicle-stimulating hormone, luteinizing hormone, estradiol, thyroid-stimulating hormone, free thyroxine, prolactin, dehydroepiandrosterone (DHEA), cortisol, sex hormone binding globulin (SHBG), triiodothyronine (T3), Thyroxine (T4), thyroid stimulating hormone (TSH), thyroid peroxidase antibodies (TPO antibodies), and other biomarkers.
  • E3G0 oestrone-3 -glucuronide
  • luteinizing hormone luteinizing hormone
  • FSH follicle stimulating hormone
  • DHEA dehydroepian
  • reaction substances and/or testing substances configured for detection of Chlamydia trachomatis include individual or a cocktail of deoxyribonucleic acid (DNA)-based aptamers or any permutation of the sequences listed in TABLE 1 and/or individual or a cocktail of antibody clones listed in TABLE 1.
  • DNA deoxyribonucleic acid
  • reaction substances and/or testing substances configured for detection of Neisseria gonorrhoeae include individual or a cocktail of deoxyribonucleic acid (DNA)-based aptamers or any permutation of the sequences listed in TABLE 2 and/or individual or a cocktail of antibody clones listed in TABLE 2.
  • DNA deoxyribonucleic acid
  • aptamers e.g., aptamers listed in TABLE 2 for detection of Neisseria Gonorrhoeae are modified by a biotin or -SH group or any other modification at the 5’ and/or 3’ terminal of the aptamer.
  • the system is configured to detect presence of Neisseria gonorrhoeae from a sample acquired from the subject, such that the target material includes one or more specific regions of biological material (e.g., tissue content, cellular content, protein content, amino acid content, nucleic acid content, etc.) of Neisseria gonorrhoeae, the reaction substances are configured to bind to specific regions of Neisseria gonorrhoeae, and/or the testing substances are configured to bind to specific regions of Neisseria gonorrhoeae.
  • biological material e.g., tissue content, cellular content, protein content, amino acid content, nucleic acid content, etc.
  • the target material of Neisseria gonorrhoeae includes individual proteins (and homologs) or a cocktails of proteins (and homologs) including one or more of Uniprot ID numbers: P95359 (SEQ ID NO 23), A0A1D3HF49 (SEQ ID NO 24), P05430 (SEQ ID NO 25), Q02219 (SEQ ID NO 26), Q51006 (SEQ ID NO 27), Q5F942 (SEQ ID NO 28), B4RQH9 (SEQ ID NO 29), Q5F6W5 (SEQ ID NO 30), P29842 (SEQ ID NO 31), Q5F542 (SEQ ID NO 32), B4RLT9 (SEQ ID NO 33), D6H5Z3 (SEQ ID NO 34), and Q5F651 (SEQ ID NO 35); and GenBank/NCBI Accession Numbers: YP_208979.1 (SEQ ID NO 75), KXI24787.1 (SEQ ID NO ).
  • the reaction substances and/or testing substances configured for detection of Trichomonas vaginalis include individual or a cocktail of deoxyribonucleic acid (DNA)-based aptamers or any permutation of the sequences listed in TABLE 3 and/or individual or a cocktail of antibody clones listed in TABLE 3.
  • Trichomonas vaginalis include individual or a cocktail of deoxyribonucleic acid (DNA)-based aptamers or any permutation of the sequences listed in TABLE 3 and/or individual or a cocktail of antibody clones listed in TABLE 3.
  • aptamers for detection of Trichomonas vaginalis are modified by a biotin or -SH group or any other modification at the 5’ and/or 3’ terminal of the aptamer.
  • the system is configured to detect presence of Trichomonas vaginalis from a sample acquired from the subject, such that the target material includes one or more specific regions of biological material (e.g., tissue content, cellular content, protein content, amino acid content, nucleic acid content, etc.) of Trichomonas vaginalis, the reaction substances are configured to bind to specific regions of Trichomonas vaginalis, and/or the testing substances are configured to bind to specific regions of Trichomonas vaginalis.
  • biological material e.g., tissue content, cellular content, protein content, amino acid content, nucleic acid content, etc.
  • the target material of Trichomonas vaginalis includes individual proteins (and homologs) or a cocktails of proteins (and homologs) including one or more of: NCBEGenBank Accession numbers: EAX87747.1 (SEQ ID NO 41), EAY21310.1 (SEQ ID NO 42), EAX96596.1 (SEQ ID NO 43), EAY19137.1 (SEQ ID NO 44), EAY01676.1 (SEQ ID NO 45), EAX86868.1 (SEQ ID NO 46), EAX98121.1 (SEQ ID NO 47), EAY18961.1 (SEQ ID NO 48), AAA91133.1 (SEQ ID NO 49), AAC48339.1 (SEQ ID NO 50), and AAC72899.1 (SEQ ID NO 51).
  • the target material of Trichomonas vaginalis includes lipoglycans or lipopolysaccharides of the Trichomonas vaginalis species.
  • the labels used include one or more of: gold nanoparticles, colored latex beads, magnetic particles, carbon nanoparticles, cellulose nano beads, selenium nanoparticles, silver nanoparticles, quantum dots, up converting phosphors, organic fluorophores, textile dyes, enzymes, liposomes and labels.
  • the conjugation of the substance that binds to a specific region of a pathogen and the label is stable for at least about 1, 3, 5, 7, 10, 12, or 14 or more days. In some embodiments, the conjugation is stable for at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more weeks. In some embodiments, the conjugation is stable for at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or more months. In some embodiments, the conjugation is stable for at least about 1, 2, 3, 4, 5, or more months.
  • the conjugation is stable when at least 50%, 60%, 70%, 80%, 90%, 95%, 98%, 99%, 99.5% of the conjugates are functional (e.g., labeling the true positive and/or not labeling the false negative) and/or at most 30%, 25%, 20%, 15%, 10%, 5%, 2.5%, 1% or 0.5% of the conjugates are not functional (e.g., labeling the false positive and/or not labeling the true positive).
  • the concentration of the label is at least about 10' 12 , 10" 11 ,10' 10 , 10' 9 , 10' 8 , 10' 7 , or 10' 6 M. In some embodiments, the concentration of the label is at most about IO" 11 ,! ⁇ " 10 , 10' 9 , 10' 8 , 10' 7 , 10' 6 , 10' 5 or 10' 4 M. In some embodiments, the concentration of the label is about 10' 12 , 10' 11 , 10' 10 , 10' 9 , 10' 8 , 10' 7 , or 10' 6 M.
  • the label is capable of generate a direct signal after encountering the analyte (e.g., the specific region that the conjugated substance binds to). In some embodiments, the label generates a signal after an additional step.
  • the device comprises more than one label.
  • the more than one label can be composed of same or different material(s).
  • the more than one label can generate same or different signals.
  • the labels used include Cellulose NanoBeads.
  • Cellulose NanoBeads e.g., NanoActrM
  • Cellulose nanobeads are highly stable, deeply colored particles that have demonstrated appropriate performance.
  • the labels used include latex beads.
  • Latex beads are inert and spherical, which have high affinity to biomolecules and can be functionalized.
  • the labels used include gold nanoparticles.
  • the gold nanoparticles include colloidal gold. Colloidal gold is inert and spherical, which have high affinity to biomolecules and can be functionalized.
  • the average diameter of the gold nanoparticles is about 5 to 150 nm. In some embodiments, the average diameter of the gold nanoparticles is no greater than 150 nm or 200 nm. In some embodiments, the average diameter of the gold nanoparticles is about 40 nm. In some embodiments, the average diameter of the gold nanoparticles is about 30 nm.
  • the average diameter of the gold nanoparticles is about 60 nm. In some embodiments, the average diameter of the gold nanoparticles is about 5 to 25, 5 to 50, 5 to 75, 5 to 100, 5 to 125, 5 to 150, 5 to 175, 5 to 200, 25 to 50, 25 to 75, 25 to 100, 25 to 125, 25 to 150, 25 to 175, 25 to 200, 50 to 75, 50 to 100, 50 to 125, 50 to 150, 50 to 175, 50 to 200, 75 to 100, 75 to 125, 75 to 150, 75 to 175, 75 to 200, 100 to 125, 100 to 150, 100 to 175, 100 to 200, 125 to 150, 125 to 175, 125 to 200, 150 to 175, 150 to 200, or 175 to 200 nm, each inclusive.
  • the labels used include Europium ions.
  • Europium ion is chelated by isothiocyanate. Isothiocyanate can be functionalized and has high affinity to biomolecules. Europium ions are highly fluorescent and have demonstrated appropriate performance over standard labels in lateral flow applications.
  • the labels used include a magnetic particle or aggregate.
  • the magnetic particle or aggregate can produce a signal, wherein the signal can be read by an optical strip reader or magnetic assay reader.
  • the magnetic particle or aggregate comprises one or more iron oxide particle.
  • the one or more iron particles comprise FesCU particles.
  • the one or more iron oxide particles are modified with polyethylene glycol.
  • the one or more iron oxide particles are crosslinked with poly-L-lysine.
  • the labels used include a fluorescent or luminescent material.
  • the label includes an organic fluorophore (e.g., rhodamine).
  • the label includes a fluorescent microsphere.
  • the label includes a nanomaterial.
  • the nanomaterial includes quantum dots.
  • the quantum dots are encapsulated into a nanobead, thereby improving the detection sensitivity.
  • the labels used include at least two or more different quantum dots, wherein the different quantum dots generate different colors.
  • the labels used include upconverting phosphors (UCP).
  • the UCP are characterized with their excitation in infra-red region and emission in high energy visible region.
  • the UCP are characterized with the absence of auto fluorescence or the absence a significant level of auto fluorescence.
  • the average diameter of UCP is about 10 nm to 1 um.
  • the average diameter of UCP is about 10 to 50, 10 to 100, 10 to 200, 10 to 300, 10 to 400, 10 to 500, 10 to 750, 50 to 100, 50 to 200, 50 to 300, 50 to 400, 50 to 500, 50 to 750, 50 to 1,000, 100 to 200, 100 to 300, 100 to 400, 100 to 500, 100 to 750, 100 to 1,000, 200 to 300, 200 to 400, 200 to 500, 200 to 750, 200 to 1,000, 300 to 400, 300 to 500, 300 to 750, 300 to 1,000, 400 to 500, 400 to 750, 400 to 1, 000, 500 to 750, 500 to 1,000, or 750 to 1,000 nm, each inclusive.
  • the average diameter of UCP is about 40 to 400 nm. In some embodiments, the average diameter of UCP is about 40 nm.
  • the labels used include fluorescent europium nanoparticles.
  • the fluorescent europium nanoparticles comprise europium III nanoparticles.
  • the average diameter of europium nanoparticles is about 100 to 1,000 nm. In some embodiments, the average diameter of europium nanoparticles is about 400 to 600 nm. In some embodiments, the average diameter of europium nanoparticles is about 500 nm (e.g., 520 nm).
  • the labels used include silica nanoparticles.
  • the label comprises lanthanide chelate-loaded silica nanoparticles.
  • the labels used include a fluorescent microsphere.
  • the labels used include an enzyme.
  • the enzyme is horse-radish peroxidase (HRP).
  • the enzyme is alkaline phosphatase (AP).
  • the enzyme is Glucose oxidase.
  • the enzyme is Urease.
  • the amplification of the detectable signal is obtained by reacting the enzyme with one or more substrates or additional enzymes and substrates to produce a detectable reaction product.
  • the labels used include colloidal carbon.
  • Unstabilized carbon can be used to produce carbon sols suitable for protein adsorption. Their carbon sols are formed by suspending carbon particles of well-defined particle sizes in distilled water or low ionic strength buffers, sonicated or vigorously agitated, followed by centrifugation. These unstabilized carbon sols were flocculated easily by salt. However, when coated with macromolecules such as antibodies, they were “protected” from flocculation. In practice, increasing amounts of a macromolecule are incubated with a fixed amount of non-stabilized carbon aqueous sol under defined conditions to determine the “minimal protective amount”.
  • the optimal pH for adsorption can be determined by one of ordinary skill in the art. Unlike colloidal gold, in which the conjugation of protein to colloidal gold is near instantaneous, adsorption onto colloidal carbon takes a longer time from one to several hours. Colloidal carbon has appropriate properties in terms of stability and high color contrast on a membrane.
  • the testing zone is fluidly coupled to the reaction zone and includes one or more testing substances corresponding to the target material in the target sample solution.
  • the testing zone includes one or more immobilized substances, such as one or more substances listed in TABLES 1-3.
  • the immobilized substances bind to specific regions of target material of agents or biomarkers associated with the health condition(s) of interest.
  • the specific region(s) are the same as the region(s) that the non-immobilized (i.e. capable of migrating downstream) substance in the reaction zone binds to.
  • the specific region(s) are different from the region(s) that the non-immobilized (i.e. capable of migrating downstream) substance(s) in the reaction zone bind to.
  • the target material-reaction substance complexes flow from the reaction zone to the testing zone, where the testing zone includes a first testing substance retained at a first region of the testing zone, where the first testing substance preferentially couples to the first target of target material.
  • the testing zone can optionally include a second testing substance retained at a second region of the testing zone, where the second testing substance preferentially couples to the second target of target material.
  • the first testing substance and the second testing substance are thus immobilized within the reaction zone, and the first and the second regions are test lines within the testing zone.
  • the first and the second regions can alternatively be defined in another manner (e.g., as dots, as areas, as patterns, etc.) within the testing zone.
  • the testing zone can include more than two testing substances, in relation to assays performed on different types of target material (e.g., related to different health conditions).
  • the testing zone only includes a single testing substance coupled to a target of a target material when the target material is present.
  • the affinity between the immobilized or non-immobilized substance(s) and the target material to which the substance(s) specifically bind when they are specifically bound to each other in a binding complex is characterized by a KD (dissociation constant) of 10-5 M or less, 10-6 M or less, such as 10-7 M or less, including 10-8 M or less, e.g., 10-9 M or less, 10-10 M or less, 10-11 M or less, 10-12 M or less, 10-13 M or less, 10-14 M or less, 10-15 M or less, including 10-16 M or less.
  • KD dissociation constant
  • the affinity between the immobilized testing substance in the testing zone and the target material of interest from the sample is about equal to or stronger than the affinity between the non-immobilized reaction substance in the reaction zone and the same target material. In some embodiments, the affinity between the immobilized testing substance in the testing zone and the target material is at least about 1.5- fold, 2-fold, 3-fold, 4-fold, 5-fold than the affinity between the non-immobilized reaction substance in the reaction zone and the same target material.
  • the affinity between the immobilized testing substance in the testing zone and the target material of interest from the sample is about equal to or weaker than the affinity between the non-immobilized reaction substance in the reaction zone and the same target material. In some embodiments, the affinity between the immobilized testing substance in the testing zone and the target material is at most about 90%, 80%, 70%, 60%, or 50% of the affinity between the non-immobilized reaction substance in the reaction zone and the same target material.
  • the testing zone further includes a substance that binds to a biomarker of pregnancy.
  • the biomarker(s) include one or more of human chorionic gonadotropin (hCG), activin A, pregnancy-associated plasma protein-A (PAPP-A), human placental lactogen (hPL), A disintegrin and Metalloprotease- 12 (ADAM- 12), pregnancy-specific beta glycoprotein 1 (SP-1), placental mRNAs, progestrerone, Inhibin A, Vascular Endothelial Growth Factor (VEGF), Placental-like growth factor (P1GF), Leukemic Inhibitory Factor, Glycodelin, Mucin-1, Adrenomedullin, and other biomarkers.
  • hCG human chorionic gonadotropin
  • PAPP-A pregnancy-associated plasma protein-A
  • hPL human placental lactogen
  • ADAM- 12 A disintegrin and Metalloprotease- 12
  • SP-1 pregnancy-specific beta glycoprotein 1
  • the testing zone further includes a substance that binds to a biomarker of fertility.
  • the biomarker(s) include one or more of: oestrone-3 -glucuronide (E3G0, luteinizing hormone, follicle stimulating hormone (FSH), estrogen, progesterone, testosterone, anti-mullerian hormone, follicle-stimulating hormone, luteinizing hormone, estradiol, thyroid-stimulating hormone, free thyroxine, prolactin, dehydroepiandrosterone (DHEA), cortisol, sex hormone binding globulin (SHBG), triiodothyronine (T3), Thyroxine (T4), thyroid stimulating hormone (TSH), thyroid peroxidase antibodies (TPO antibodies), and other biomarkers.
  • E3G0 oestrone-3 -glucuronide
  • FSH follicle stimulating hormone
  • DHEA dehydroepiandrosterone
  • SHBG sex
  • the strip also includes a control zone.
  • the control zone is located downstream from the loading zone.
  • the control zone is located upstream or downstream from, or overlaps with the reaction zone.
  • the control zone is located upstream or downstream, or overlaps from the testing zone.
  • the control zone is located downstream from both the reaction zone and the testing zone.
  • the control zone may include a control substance retained at the control zone.
  • the control substance is immobilized.
  • the control substance binds to any particle.
  • the substance binds to a mobile control binding agent (a control binding agent that is not immobilized).
  • the mobile control binding agent is or includes the non-immobilized reaction substance in the reaction zone.
  • the mobile control binding agent is or includes an agent in the sample or a solution the sample is prepared in.
  • the control zone includes two or more substances that bind to two or more mobile control binding agents.
  • the two or more mobile control binding agents are from different sources (e.g., one is from the sample or a solution the sample is prepared in, and another from the non-immobilized substance originally in the reaction zone).
  • the target material when received into the loading zone of the test strip 135, the target material flows to the reaction zone.
  • the target material-reaction substance complexes flow from the reaction zone to the testing zone.
  • the sample material including the target material and/or other material flows from the testing zone to the control zone, which includes a control substance retained at the control zone.
  • the sample material including the target material and/or other material flows from the testing zone to the control zone, which includes a control substance retained at the control zone, where the control substance does not preferentially couple to the target material and/or binds to any substance (e.g., binds non-specifically to different materials).
  • the control substance is immobilized at the control zone and can be immobilized along a line of the control zone or in another manner (e.g., as a dot, as an area, as a pattern).
  • the system achieves a sensitivity of detecting the presence of a specific agent or biomarker in each of the strips of at least about 50%, 55%, 60%, 65%, 70%, 75%, 80%, 82.5%, 85%, 90%, 92.5%, 95%, 96%, 97%, 98%, or 99%.
  • the system detects two or more different agents or biomarkers with a sensitivity for at least two agents/biomarkers being both about or more than 50%, 55%, 60%, 65%, 70%, 75%, 80%, 82.5%, 85%, 90%, 92.5%, 95%, 96%, 97%, 98%, or 99%.
  • the system detects three or more different agents or biomarkers with a sensitivity for at least three agents/biomarkers being both about or more than 50%, 55%, 60%, 65%, 70%, 75%, 80%, 82.5%, 85%, 90%, 92.5%, 95%, 96%, 97%, 98%, or 99%.
  • the system achieves a specificity of detecting the presence of a specific agent or biomarker of at least about 50%, 55%, 60%, 65%, 70%, 75%, 80%, 82.5%, 85%, 90%, 92.5%, 95%, 96%, 97%, 98%, or 99%.
  • the system detects two or more different agents or biomarkers with a specificity for at least two agents/biomarkers being both about or more than 50%, 55%, 60%, 65%, 70%, 75%, 80%, 82.5%, 85%, 90%, 92.5%, 95%, 96%, 97%, 98%, or 99%.
  • the system detects three or more different agents or biomarkers with specificity for at least three agents/biomarkers being both about or more than 50%, 55%, 60%, 65%, 70%, 75%, 80%, 82.5%, 85%, 90%, 92.5%, 95%, 96%, 97%, 98%, or 99%.
  • the signa includes, is coupled to, or otherwise communicates with a detection system.
  • the signal output device is coupled to the detection system.
  • the detection system includes an optical reader (e.g., an optical strip reader).
  • the optical reader measures the intensity of colors produced at test and control lines.
  • the intensity of colors is recorded by an imaging software (e.g., an application on a computer, such as a mobile app).
  • the intensity of colors are recorded by a camera and then processed by an imaging software.
  • the optical system comprises a source of light.
  • the source of light comprises a monochromatic light.
  • the optical system is an automated system.
  • the optical system is a manual system.
  • the detection system includes a fluorescence reader (e.g., a fluorescence strip reader).
  • the fluorescence reader measures the fluorescence intensity of test and control lines.
  • the detection system includes a photoelectric sensor.
  • the photoelectric sensor measures photoelectrons produced as a result of the colloidal gold being exposed to a light source.
  • the detection system includes a magnetic reader (e.g., a magnetic strip reader).
  • the detection system comprises an electrochemical detector.
  • the detection system comprises a digital device, such as, but not limited to, a mobile device, tablet, computer, and the like.
  • the system does not include an external detection system.
  • the systems described herein produce a signal that can be assessed by the eye (e.g., with visual observation).
  • FIGS. 5-8 illustrates phases of use of the system components shown in FIG. 1.
  • the sample including the target material is mixed with buffer A contained within the dropper tube 110 to extract the target material from the sample.
  • the sample and buffer A are mixed with the sample collection tool 105 to form a sample mixture.
  • the sample and buffer A may be mixed with any suitable stirrer.
  • the dropper cap 115 is then placed onto the dropper tube 110.
  • FIG. 11 provides a flow chart of instructions for using the sample kit device. This flow chart of instructions can be included as instructions for use in the sample kit for a user.
  • the sample material including the target material is dispensed from the extraction container into the sample wells of the testing container 120.
  • Each sample well (150, 160, 170) of the testing container 120 includes a buffer B that is personalized for a particular health condition.
  • the testing container also includes a base 180 that holds the upper portion 190 of the testing container in place.
  • the base is configured to hold the upper portion of the testing container upright or flat.
  • the signal output device (not shown) is sized fit over the upper portion 190 of the target container 120 and fits flush against the upper portion 200 of the base 180.
  • the target wells of the target containers are sealed with a sealant 140 (e.g., tape or foil seal) to cover the wells.
  • a sealant 140 e.g., tape or foil seal
  • This seal is configured to be peeled off by a user (e.g. subject) when ready to use.
  • the seal wrap 140 is configured to be peeled before placement of the signal output device onto the testing container.
  • the contents of the sample wells are mixed with a stirrer 125 to form a sample target solution.
  • mixing may also be achieved via beads and/or inert material to enable a device free mixing technique.
  • a shaker or vortex may be used for mixing.
  • the mixing stirrer 125 in the kit is configured to stir the contents as samples may be viscous.
  • a shaker or vortex may be used for use in lab or point of care.
  • the signal output device 130 is then inserted on top of the sample wells of the testing container 120 for development of a test signal.
  • Test Strips Tl-Tn
  • sample well of testing Container Bl -Bn
  • the device snaps into the testing container to begin development.
  • Non-limiting examples of the test strips dipped in each well of the testing container is shown in FIG. 8B.
  • the signal may be interpreted by the eye.
  • the signal output device may be further signal processed using a camera on the smartphone or optical reader or fluorimeter.
  • the data can be viewed by the user or be sent to a provider for next steps in patient care via telehealth.
  • the provider can in turn provide necessary guidance to the user and be able to send the prescription directly to the user.
  • FIG. 9 illustrates data showing system design is scalable for functional detection for different health conditions.
  • the data shows that the system can the accurately detect the presence and/or absence of various diseases, including strep, HCG, chlamydia, gonorrhea, and trichomonas.
  • the data also shows that the system can provide visual indications of the presence and/or absence of the various diseases.
  • the results of the data provide an indication of the scalability of the system.
  • each test kit has an ID associated with it.
  • This ID would encapsulate multiple variables which could identify the device some of which would include Lot ID, Batch ID, Test ID, Expiration Date, Seller, Re-seller information, etc. Capture of the ID could be either based on QR code or user input.
  • the ID can help provide additional services to the end user. Some of the services may include, but are not limited to, connecting to telehealth, various helplines, clinics, prescriptions.
  • the signal output device is read using a smartphone or computer device.
  • the smartphone can include a software used to take an image of the signal output device windows showing the test strips, and the smartphone can provide the result to the user indicating whether the user tested positive or negative, or indicating a particular level of an agent present in the sample.
  • the smartphone or computer device can be used to read the signal provided by a label or tag on the signal output device.
  • a label and/or tag include a visual label, a fluorophore label, a gold label, a CNB label, or the like.
  • an image can be taken of the windows showing the test strips, and the label/tag may be visible in the image as a readable test result for the user or the phone may translate the test result for the user.
  • the phone includes a mobile software application stored on a computer readable medium and executable by a processor.
  • the mobile application can be an application corresponding to the sample kit including a user interface that allows the user to take images or otherwise input information into a user interface, and to be presented with test results.
  • the user’s family members, physician, nurse, or members of the medical team can also have access to a medical side mobile or computer application that receives information from the user’s mobile application about the user’s test.
  • the medical team can read the results, send comments to the user, send an interpretation of the test results, among other interactions.
  • the sample kit includes a telehealth system that allows the physician to interact with the user including scheduling a video conference or phone call to discuss the test results.
  • the medical team can prescribe medication or therapy to treat the condition if the user has a positive test. The physician can send the prescription to the pharmacy based on the test results received through the mobile application.
  • the user can coordinate the delivery or pickup of the prescription through the mobile application, and coordinate refills of the prescription with the medical team and pharmacy.
  • the system is an end-to-end computer telehealth system where a medical team can prescribe to the user a test in which the user receives the sampling kit in the mail or from the store.
  • the user takes the test, and uses the mobile application to read the test results.
  • the mobile application sends the test results over a network or the internet to the medical team.
  • the medical team takes various actions based on the results including providing a prescription to the pharmacy, and the user then receives the prescription and can continue to be monitored by the medical team through the mobile application.
  • Embodiments may also relate to an apparatus for performing the operations herein.
  • This apparatus may be specially constructed for the required purposes, and/or it may comprise a general-purpose computing device selectively activated or reconfigured by a computer program stored in the computer.
  • a computer program may be stored in a non- transitory, tangible computer readable storage medium, or any type of media suitable for storing electronic instructions, which may be coupled to a computer system bus.
  • any computing systems referred to in the specification may include a single processor or may be architectures employing multiple processor designs for increased computing capability.
  • Standard abbreviations may be used, e.g., bp, base pair(s); kb, kilobase(s); pl, picoliter(s); microliters (pl), s or sec, second(s); min, minute(s); h or hr, hour(s); aa, amino acid(s); kb, kilobase(s); bp, base pair(s); nt, nucleotide(s); i.m., intramuscular(ly); i.p., intraperitoneal(ly); s.c., subcutaneous(ly); and the like.
  • control solution represents the result output of the sample health kit as described in the present disclosure
  • control limit represents the actual, true result based on the known sample tested.
  • the indication status of the test panel is assessed visually by the naked eye for the presence or absence of a health condition.
  • a test zone that shows a visual, physical line on the test zone “window” will indicate that the result is positive (e.g., the sample does include the analyte/health condition being tested for).
  • a test zone that does not show any visual, physical line on the test zone “window” will indicate that the result is negative (e.g., the sample does not include the analyte being tested for).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Food Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Pathology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Virology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

La présente divulgation concerne des systèmes, des méthodes, des dispositifs et des kits multiplexés permettant de détecter le statut d'un ou plusieurs états de santé en seul dispositif. L'invention comprend un récipient d'extraction destiné à la réception d'un échantillon et à l'extraction d'une substance cible de l'échantillon; un récipient de test doté d'au moins une première et une seconde cupule contenant un ou plusieurs tampons destinés à recevoir la substance cible extraite, et un dispositif de sortie de signal comprenant un boîtier contenant deux bandes ou plus, chaque bande comportant a) une zone de chargement; b) une zone de réaction; c) une zone de test; et d) une zone de contrôle. Le système et les méthodes peuvent être appropriées pour évaluer la santé sexuelle d'un ou plusieurs sujets, en lien avec une grossesse, la fertilité et/ou des infections sexuellement transmissibles provoquées par un ou plusieurs agents.
PCT/US2021/044091 2020-08-01 2021-07-31 Méthodes fiables et évolutives de détection et plate-forme pour dispositifs médicaux de consommateur WO2022031560A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP21852382.7A EP4189393A1 (fr) 2020-08-01 2021-07-31 Méthodes fiables et évolutives de détection et plate-forme pour dispositifs médicaux de consommateur

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063060041P 2020-08-01 2020-08-01
US63/060,041 2020-08-01

Publications (1)

Publication Number Publication Date
WO2022031560A1 true WO2022031560A1 (fr) 2022-02-10

Family

ID=80117683

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2021/044091 WO2022031560A1 (fr) 2020-08-01 2021-07-31 Méthodes fiables et évolutives de détection et plate-forme pour dispositifs médicaux de consommateur

Country Status (2)

Country Link
EP (1) EP4189393A1 (fr)
WO (1) WO2022031560A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023170544A1 (fr) * 2022-03-07 2023-09-14 Das Tanisha Dispositif analytique en papier (pad) pour la détection d'infections vaginales

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5415994A (en) * 1993-08-02 1995-05-16 Quidel Corporation Lateral flow medical diagnostic assay device with sample extraction means
US20140160877A1 (en) * 2010-12-20 2014-06-12 Boehringer Ingelheim Microparts Gmbh Method for mixing at least one sample solution having at least one reagent, and device
US20150010992A1 (en) * 2010-07-20 2015-01-08 Quantrx Biomedical Corporation Optical reader systems and lateral flow assays

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5415994A (en) * 1993-08-02 1995-05-16 Quidel Corporation Lateral flow medical diagnostic assay device with sample extraction means
US20150010992A1 (en) * 2010-07-20 2015-01-08 Quantrx Biomedical Corporation Optical reader systems and lateral flow assays
US20140160877A1 (en) * 2010-12-20 2014-06-12 Boehringer Ingelheim Microparts Gmbh Method for mixing at least one sample solution having at least one reagent, and device

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023170544A1 (fr) * 2022-03-07 2023-09-14 Das Tanisha Dispositif analytique en papier (pad) pour la détection d'infections vaginales

Also Published As

Publication number Publication date
EP4189393A1 (fr) 2023-06-07

Similar Documents

Publication Publication Date Title
US20210223243A1 (en) Test device for detecting an analyte in a saliva sample and method of use
EP1563100B1 (fr) Immuno-pcr sandwich par deplacement
US20230092810A1 (en) Fetal cell capture module and microfluidic chip for fetal cell capture and methods for using the same
US11782060B2 (en) Reliable, comprehensive, and rapid sexual health assessment
WO2013074520A2 (fr) Détection, isolement et analyse de cellules rares dans des liquides biologiques
EP2715368B1 (fr) Dosages immunologiques de la tsh et procédés de réalisation des dosages immunologiques de la tsh en présence de contaminants endogènes dans des formats de lavage restreints
US9199234B2 (en) TSH antibodies for point-of-care immunoassay formats
Lyu et al. Automatic label-free immunoassay with high sensitivity for rapid detection of SARS-CoV-2 nucleocapsid protein based on chemiluminescent magnetic beads
JP2021035372A (ja) サンプル分析のための方法、機器、及びシステム
EP2715356B1 (fr) Immunoessais de tsh employant des réactifs de piégeage pour la réaction croisée d'analogues d'hormone endocrine glycoprotéique
CN107003312B (zh) 用于埃博拉和其他传染病的实时诊断测试(rdt)的方法和装置
CN110073195B (zh) 提取外泌体以及与之结合的生物大分子的方法以及试剂盒
WO2022031560A1 (fr) Méthodes fiables et évolutives de détection et plate-forme pour dispositifs médicaux de consommateur
US10935545B2 (en) Simultaneous analysis method for multiple targets using multiple metal nano-tags
US20220011301A1 (en) Streptavidin-coated solid phases with a member of a binding pair
CN113624977A (zh) SARS-CoV-2感染诊断方法
US20120202297A1 (en) Gender determination method
WO2018056700A1 (fr) Procédé de diagnostic rapide à haute sensibilité d'une puce de diagnostic unique comprenant une réaction et une analyse
US20220003765A1 (en) Kit and Method
WO2023007352A1 (fr) Dispositif de test rapide pour la détection de virus sras-cov-2 et la production d'anticorps relatifs
CN117280211A (zh) 用于冠状病毒感染的高灵敏度检测的侧向流动装置及其制造和使用方法
US20170097357A1 (en) Assay
EP3387154A1 (fr) Système automatisé d'amélioration d'argent

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21852382

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2021852382

Country of ref document: EP

Effective date: 20230301